Renal Transplantation and Raltegravir in HIV-Infected Patients
NCT ID: NCT01453192
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
27 participants
INTERVENTIONAL
2011-12-31
2015-11-30
Brief Summary
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Detailed Description
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In addition HIV infection may be modified together with cardiovascular risk. Patients participating to this study will receive after transplantation antiretroviral regimen including Raltegravir.
Raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the treatment of choice to be associated with immunosuppressive drugs.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Raltegravir
Raltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease
Raltegravir
Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease
Interventions
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Raltegravir
Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HIV-1-infected patients treated by a three-drug ARV regimen
* Immuno-virologic criteria at renal transplantation: undetectable viral load (\<50 copies/mL) and CD4 \>200/mm3 for at least three months on stable ARV
* Age \>18 years and \<70 years
* Effective contraception for women
* Written informed consent
* Patient with social security coverage
Exclusion Criteria
* Hepatic cirrhosis
* Serious psychiatric illness history
* EBV or HHV8 lymphoproliferation (lymphoma, systemic Kaposi's sarcoma or multifocal Castleman's disease)
* History of PML
* HTLV-1 seropositivity
* Severe pulmonary or cardiovascular disease with poor short-term vital prognosis
* Patient with AgHBs+
* History of cryptosporidiosis
* History of fungal infection with multi resistant fungi not likely to respond to oral antifungal therapy
* Impossibility or refusal of Raltegravir switch, decision made by doctor or patient
* Temporary:
* Recent malignancy (between 2 and 5 years according to type)
* HPV-related cervical or anal disease: carcinoma in situ, AIN III, CIN III in remission for less than three years
* Active infection
* HCV infection (PCR-positive)
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Philippe GRIMBERT, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Henri-Mondor
Dominique COSTAGLIOLA, PHD
Role: STUDY_DIRECTOR
INSERM U943
Locations
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Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse
Bordeaux, , France
CHU De Caen, Service de Néphrologie Hémodialyse
Caen, , France
Hôpital Henri Mondor, Service de Néphrologie Transplantation
Créteil, , France
Hôpital Kremlin Bicêtre, Service de Néphrologie
Le Kremlin-Bicêtre, , France
CHRU Lille, Service de néphrologie
Lille, , France
CHU de Nantes, Service de Néphrologie et Immunologie Clinique
Nantes, , France
Hôpital Pasteur, Service de Néphrologie - Transplantation
Nice, , France
Hopital Saint Louis, Service de Néphrologie
Paris, , France
Hôpital Necker, Service de Néphrologie adulte
Paris, , France
Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale
Paris, , France
Hôpital civil, Service de Néphrologie et Transplantation
Strasbourg, , France
Hôpital Foch, Service de Néphrologie Transplantation
Suresnes, , France
Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation
Toulouse, , France
Hôpital Bretonneau, Service de Néphrologie
Tours, , France
Countries
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Related Links
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French National Agency for Research on AIDS and viral Hepatitis
Other Identifiers
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ANRS 153 TREVE
Identifier Type: REGISTRY
Identifier Source: secondary_id
2011-001004-35
Identifier Type: -
Identifier Source: org_study_id
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